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OpenTrials
Completed

NCT Number: NCT00889837

Staccato Loxapine Pulmonary Safety in Patients With COPD

The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

About this study

To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking.

Exclusion criteria

  • History of asthma, or any other acute or chronic pulmonary disease.

Treatment and study plan

Inhaled loxapine

Drug

Staccato Loxapine, 10 mg x 2 doses, 10 hours apart

Inhaled placebo

Drug

Staccato Placebo, inhalations x 2 , 10 hours apart

Primary outcomes

  1. Change in FEV1 from baseline by spirometry

    Time frame: at each post-treatment time point (15 min to 34 hr)

Secondary outcomes

  1. Change in FVC from baseline by spirometry

    Time frame: at each post-treatment time point (15 min to 34 hr)

  2. Treatment emergent adverse events

    Time frame: Post-treatment time points

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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